Death | 合法醫療器材資訊網

2021年2月3日—BostonScientificbeganrecallingthesubcutaneousimplantablecardioverterdefibrillator(S-ICD)systemelectrodeinDecemberafteridentifying ...

Dive Brief:

FDA has designated a recall of Boston Scientifics Emblem subcutaneous electrode as a Class I event in light of the 26 serious injuries and one death associated with the device.[1]

Boston Scientific began recalling the subcutaneous implantable cardioverter defibrillator (S-ICD) system electrode in December after identifying the potential for the device to fracture, preventing the technology from slowing very fast heartbeats associated with cardiac arrest. [2]

To mitigate the risk, Boston Scientific asked physicians to enroll users in remote monitoring, and ask patients to do weekly checks. Physicians should also perform a system follow-up every three months.

Dive Insight:

Around 90,000 patients have re...

Boston Scientific Corporation Recalls EMBLEM S | 合法醫療器材資訊網

Boston Scientific Recalls EMBLEM S | 合法醫療器材資訊網

2021年2月10日 — Reason for Recall ... Boston Scientific is recalling the EMBLEM S-ICD Subcutaneous Electrode because of increased risk of fractures at a specific ... Read More

Boston Scientific's ICD recall gets 2nd Class I label from FDA ... | 合法醫療器材資訊網

2021年2月22日 — FDA has categorized another recently identified problem with Boston Scientific's Emblem subcutaneous implantable cardioverter defibrillator (S- ... Read More

Death | 合法醫療器材資訊網

2021年2月3日 — Boston Scientific began recalling the subcutaneous implantable cardioverter defibrillator (S-ICD) system electrode in December after identifying ... Read More

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2021年2月23日 — FDA Class I Recall: Boston Scientific EMBLEM S-ICD Cardioverter Defibrillator May Cause Serious Injury or Death ... The FDA recalled Boston ... Read More

Who is Affected by the Boston Scientific ICD Recall? | 合法醫療器材資訊網

2021年2月26日 — Unfortunately, if you have an ICD to treat an arrhythmia, you may have the Boston Scientific S-ICD which was recalled in December 2020. The ... Read More

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2021年2月12日 — The U.S. Food and Drug Administration (FDA) announced the Boston Scientific defibrillator recall on February 10, warning that the electrodes ... Read More

Boston Scientific has another serious recall on the same heart ... | 合法醫療器材資訊網

2021年2月22日 — This recall, which the company initiated with a trio of warnings in December, notified physicians that 3,350 Emblem S-ICD model A209 and A219 ... Read More

Boston Scientific EMBLEM S | 合法醫療器材資訊網

2021年2月2日 — According to the FDA, Boston Scientific's Emblem subcutaneous electrode's fracture defect has caused 26 serious injuries and one death. The ... Read More

Boston Scientific Pays Million to Settle Defective Heart ... | 合法醫療器材資訊網

Boston Scientific's latest $30 million settlement brings to $972 million the amount it has paid to resolve actions related to defective heart defibrillators. Read More

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Boston Scientific Corporation Recalls EMBLEM S | 合法醫療器材資訊網

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